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Selfmonitoring and other nonpharmacological interventions to improve the management of hypertension in primary care:
a systematic review
Liam G Glynn, Andrew W Murphy, Susan M Smith, Knut Schroeder and Tom Fahey
INTRODUCTION
ABSTRACT
Background
Patients with high blood pressure (hypertension) in the community frequently fail to meet treatment goals: a condition labelled as uncontrolled hypertension. The optimal way to organise and deliver care to hypertensive patients has not been clearly identified.
Aim
To determine the effectiveness of interventions to improve control of blood pressure in patients with hypertension.
Design of study
Systematic review of randomised controlled trials.
Setting
Primary and ambulatory care.
Method
Interventions were categorised as following: selfmonitoring; educational interventions directed to the patient; educational interventions directed to the health professional; health professional- (nurse or pharmacist) led care; organisational interventions that aimed to improve the delivery of care; and appointment reminder systems. Outcomes assessed were mean systolic and diastolic blood pressure, control of blood pressure and proportion of patients followed up at clinic.
Hypertension is largely managed in primary care and is an important public health problem in terms of associated stroke and cardiovascular events. It is mostly of unknown aetiology, easy to diagnose, and readily preventable by blood pressure reduction. Extensive epidemiological data have strengthened the well-recognised relationship between blood pressure and risk of cardiovascular disease, and have confirmed the importance of systolic blood pressure as a determinant of risk.1 However, blood pressure goals are achieved in only 2540% of the patients who take antihypertensive drug treatment,2,3 which is something that has remained unchanged for the last 40 years.4 Use of self-monitoring of blood pressure by patients and professionals has gained popularity and
Results
Seventy-two RCTs met the inclusion criteria. The trials showed a wide variety of methodological quality. Selfmonitoring was associated with net reductions in systolic blood pressure (weighted mean difference [WMD] 2.5mmHg, 95%CI = 3.7 to 1.3 mmHg) and diastolic blood pressure (WMD 1.8mmHg, 95%CI = 2.4 to 1.2 mmHg). An organised system of regular review allied to vigorous antihypertensive drug therapy was shown to reduce blood pressure and all-cause mortality in a single large randomised controlled trial.
LG Glynn, MD, FRCSI, MRCGP, MICGP, senior lecturer in general practice; AW Murphy, MD, MICGP, FRCGP, professor of general practice, National University of Ireland, Galway, Ireland. SM Smith, MD, MICGP, MRCGP, senior lecturer in primary care, Trinity College, Dublin, Ireland. K Schroeder, MRCP, MRCGP, PhD, honorary senior clinical lecturer, Academic Unit of Primary Health Care, University of Bristol, Bristol. T Fahey, MD, MFPH, FRCGP, professor of general practice, Royal College of Surgeons in Ireland Medical School, Dublin, Ireland. Address for correspondence Liam G Glynn, Discipline of General Practice, Clinical Science Institute, National University of Ireland Galway Galway, Ireland. Email: liam.glynn@nuigalway.ie Submitted: 16 March 2010; Editors response: 14 April 2010; final acceptance: 4 May 2010.
British Journal of General Practice. This is the full-length article (published online 29 November 2010) of an abridged version published in print. Cite this article as: Br J Gen Pract 2010; DOI: 10.3399/bjgp10X544113
Conclusion
Antihypertensive drug therapy should be implemented by means of a vigorous stepped care approach when patients do not reach target blood pressure levels. Selfmonitoring is a useful adjunct to care while reminder systems and nurse/pharmacist -led care require further evaluation.
Keywords
hypertension; prevention and control; primary care; systematic review.
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Systematic Review
is now recommended in particular patients in certain national and international guidelines; a recent metaanalysis of randomised trials on the subject did suggested a benefit in terms of mean blood pressure and blood pressure control.5 This systematic review aims to update and build upon previous reviews,6,7 by summarising the evidence from randomised controlled trials (RCTs) that evaluate nonpharmacological interventions to improve the management of hypertension in primary care.
METHOD
Searching and study selection
Studies of patients aged >18 years with essential hypertension in an ambulatory setting were included. The interventions comprised all those that aimed to improve blood pressure control by nonpharmacological means and were classified as:
self-monitoring; educational interventions directed to the patient; educational interventions directed to the health
The majority of patients with hypertension who take blood pressure medication fail to reach treatment goals. There is a strong evidence base for the benefits of antihypertensive drug therapy, but there is a lack of clarity on how to organise and deliver care for patients with hypertension in the community. This systematic review of 72 randomised controlled trials shows that self-monitoring leads to a significant decline in systolic and diastolic blood pressure and, as such, may be a useful adjunct to care and is likely to lead to a reduction in cardiovascular events. An organised system of regular review allied to vigorous antihypertensive drug therapy was shown to reduce blood pressure and allcause mortality. Nurse- or pharmacist-led care and appointment-reminder systems may be a promising way of improving blood pressure control, but require further evaluation.
professional;
nurse- or pharmacist-led care; organisational interventions that aimed to improve
The outcomes assessed were mean systolic and diastolic blood pressure, control of blood pressure, and the proportion of patients followed up at clinic. Original RCTs were identified by an all-language search in February 2008 of all articles (any year) in the Cochrane Controlled Trials Register and Medline (search strategy shown in Appendix 1); articles dated from January 1980 were searched on Embase. Included studies had to be RCTs with a contemporaneous control group, where patient care in the intervention group(s) was compared with either no intervention or usual care.
were examined. For the outcomes of mean systolic and diastolic blood pressure, pressure differences from baseline to final follow-up in the intervention and control groups were compared and pooled using the weighted mean difference approach.7 For the outcomes of blood pressure control and clinic attendance at follow-up, statistical and clinical significance was evaluated by means of estimating odds ratios (ORs) with 95% confidence intervals (CIs). Individual study definitions of control of blood pressure and attendance at clinic were used. For both continuous and categorical outcomes, the metaanalyses for heterogeneity were checked by visual inspection and by Cochrans C test. Pooled ORs and their 95% CIs were calculated with The Cochrane Collaboration RevMan software (version 5.02).
RESULTS
Trial flow, study characteristics, and quality assessment
The flow of studies through the stages of the systematic review is shown in Figure 1. A total of 72 trials were included in this systematic review (Characteristics of included randomized controlled trials are described in Appendix 2). The reported methodological quality of included studies was generally poor to moderate. The randomisation process was described in 30 (42%) of the 72 trials included, while only 14 (19%) had adequate allocation concealment. In 15 studies (21%), the outcome assessors were blind to the treatment allocation and losses to follow-up of 20% or more occurred in 18 (25%) of studies.
Intervention effects
The impact of interventions is summarised in Table 1 (full data available from authors). There was substantial heterogeneity for several interventions and outcomes. In these situations, pooled data are not reported but the range of results from individual RCTs are presented.
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Studies excluded with reasons (total n = 9262): Not an RCT (n = 3017) Didnt meet inclusion criteria (n = 5279) Hospital based study (n = 966)
Studies excluded with reasons (total n = 110): Not an RCT (n = 27) Didnt meet inclusion criteria (n = 55) Not usual care arm (n = 6) Outcome not relevant (n = 22)
Potentially appropriate RCTs excluded from meta-analysis, with reasons (total n = 87): Not properly randomised (n = 39) Not ambulatory care setting (n = 3) No usual care arm (n = 5) No relevant outcome (n = 19) Not hypertensive patients (n = 7) Lifestyle advice intervention (n = 7) Duplicate publication (n = 7)
blood pressure and diastolic blood pressure outcomes, pooling of results from individual RCTs produced substantial heterogeneity, so pooled mean differences are not valid. The reported mean difference in systolic blood pressure ranged from 16 mmHg to 1 mmHg, and from 9 mmHg to 7 mmHg for mean difference in diastolic blood pressure. In terms of blood pressure control, there was a trend towards improved blood pressure control and this was significant (OR 0.83; 95% CI = 0.75 to 0.91). Educational interventions directed towards the physician (n = 10 RCTs)30,4149 were not associated with a significant decrease in mean systolic blood pressure or diastolic blood pressure; control of blood pressure produced heterogeneous results (OR ranged from 0.8 to 1.1).
RCTs included in the meta-analysis (n = 72) Inteventions and outcomes in RCTs categorised as follows: Self monitoring (n = 18), SBP (n = 10), DBP (n = 12), BP control (n = 4), no usable outcome data (n = 1) Education- patient (n = 20), SBP (n = 7), DBP (n = 9), BP control (n = 5), no usable outcome data (n = 3) Education- health professional (n = 10), SBP (n = 6), DBP (n = 6), BP control (n = 6), no usable outcome data (n = 0) Nurse or pharmacist led care (n = 12), SBP (n = 5), DBP (n = 6), BP control (n = 5), no usable outcome data (n = 2), Organisation of care (n = 9), SBP (n = 5), DBP (n = 5), BP control (n = 5), no usable outcome data (n = 2) Appointment reminders (n = 8), Appointment follow up (n = 6), no usable outcome data (n = 0)
*72 unique randomised controlled trials met the inclusion criteria. Four of these trials had single or multiple companion publications or studies associated with them giving a total of 77 studies included in the analysis under the headings above.
Organisational interventions
BP = blood pressure. DBP = diastolic blood pressure. RCT = randomised controlled trial. SBP = systolic blood pressure.
Self-monitoring
With regard to self-monitoring (n = 18 RCTs), pooled data from 12 RCTs that reported on differences in mean systolic blood pressure819 showed that selfmonitoring was associated with a significant reduction of 2.5 mmHg (95% CI = 3.7 to 1.3 mmHg). Pooled data from 14 RCTs on difference of mean diastolic blood pressure,922 showed that self-monitoring was associated with a reduction of 1.8 mmHg (95% CI = 2.4 to 1.2 mmHg). In the six RCTs that reported on control of blood pressure,10,12,18,2224 there was no significant improvement in blood pressure control seen (OR 1.0, 95% CI = 0.8 to 1.2).
Organisational interventions that aimed to improve the delivery of care were described in nine RCTs.40,41,6069 For all three outcomes, pooling of results from individual RCTs produced heterogeneous results, so pooled mean differences may not be valid. Of note, the largest RCT, the Hypertension Detection and FollowUp Program (HDFP),64 produced substantial reductions in systolic blood pressure and diastolic blood pressure across the three groups (weighted mean difference 8.2/4.2 mmHg, 11.7/6.5 mmHg, 10.6/7.6 mmHg for the three strata of entry blood pressure).
Appointment-reminder systems
For appointment-reminder systems (n = 8 RCTs),7077 the pooled results although favouring the intervention for follow-up of patients (OR of being lost to follow-up 0.4, 95% CI = 0.3 to 0.5) are heterogeneous because of the single outlying RCT, and the pooled results should be treated with caution. Pooled data from two small RCTs one a three-armed study of telephone reminder, mailed reminder, and usual care,76 and the other a parallel study of SMS reminder versus usual care77 gave heterogeneous results in terms of systolic and
Educational interventions
Educational interventions directed to the patient involved 20 RCTs. Eleven RCTs reported mean difference systolic blood pressure,2535 13 RCTs reported mean difference diastolic blood pressure,2538 and seven reported blood pressure control.22,23,30,32,33,39,40 For mean difference in systolic
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Table 1. Summary of results of interventions on systolic and diastolic blood pressure, blood pressure control and follow-up at clinic.
Systolic blood pressure, mmHg Intervention Self-monitoring Education (patient) Education (physician) Pooled estimate Range of results (95% CI) from individual RCTs 2.5 (3.7 to 1.3)b
c
Diastolic blood pressure, mmHg Pooled estimate Range of results (95% CI) from individual RCTs 1.8 (2.4 to 1.2)b
c
Blood pressure control, ORa Pooled estimate Range of results (95% CI) from individual RCTs 1.0 (0.8 to 1.2) 0.8 (0.8 to 1.0)a 0.9 (0.8 to 0.9)
c
10 to 5 16 to 1 7 to 1 13 to 0 12 to 3 10 to 5
12 to 0 9 to 7 2 to 1 8 to 0 8 to 5 7 to 2
0.5 to 1.3 0.3 to 1.1 0.8 to 1.0 0.1 to 0.9 0.5 to 1.8 0.5 to 0.6
0.1 to 1.4
OR of control of blood pressure (control blood pressure threshold definition taken as that used in each individual RCT), RR <1 blood pressure control greater in intervention group, >1 blood pressure control greater in control group. bP<0.05, heterogeneous results. cNo pooled estimate reported. OR = odds ratio. RCT = randomised controlled trial. RR = relative risk.
diastolic blood pressure, but did show a significant improvement in blood pressure control, OR 0.5 (95% CI = 0.4 to 0.7).
DISCUSSION
In this systematic review, self-monitoring was associated with a significant decline in systolic blood pressure (2.5 mmHg) and diastolic blood pressure (1.8 mmHg). Although this blood pressure reduction does not appear substantial in clinical terms, it would, nonetheless, appear to be a useful adjunct to care and is likely to lead to a reduction in mortality and cardiovascular events. This appears to be confirmed in the HDFP study65,66 where an organised system of regular review allied to vigorous antihypertensive drug therapy was shown to reduce blood pressure as well as all-cause mortality. At 5-year follow-up, the reductions in blood pressure (~10 mmHg for systolic blood pressure and 5 mmHg for diastolic blood pressure) seen in this study were associated with a significant reduction in all-cause mortality (6.4% versus 7.8%, absolute risk reduction = 1.4%, numbers needed to treat = 71). Nurse- or pharmacist-led care and appointmentreminder systems may be a promising way of improving blood pressure control, but require further evaluation. A previous meta-analysis of self-monitoring produced similar findings to the current study of modest, but potentially important, benefit in systolic and diastolic blood pressure.5 This is important in light of the fact that self-monitoring is now practised by up to two-thirds of the population that has hypertension in the US and Europe.78 There are also other elements identified from this review that appear to be associated with improved
blood pressure control and are consistent with findings from observational studies and previous systematic reviews. A more recent observational study showed that antihypertensive drug therapy was initiated or changed in only 38% of episodes of care, despite documented uncontrolled hypertension for at least 6 months.79 Lack of practice organisation is associated with a failure to achieve treatment surrogate goals in hypertension, diabetes, and secondary prevention of coronary heart disease.80 This review had several limitations. Several RCTs included patients with hypertension who were treated and untreated and had differential rates of antihypertensive drug prescribing.8,18,47,76 Many RCTs contained multifaceted interventions that did not fit into a single intervention category.40,51,67 Consequently, it has been difficult to attribute how far single elements that make up complex interventions exert their independent effect on blood pressure control. Finally, several of the RCTs did not make any recommendations about the need for adjustment of target blood pressure readings when self-monitoring was the intervention being assessed, nor did they appear to anticipate lower blood pressure readings in the self-monitoring group.16,21,22,24 This may have attenuated the impact of selfmonitoring on blood pressure control because of failure to intensify treatment. Self-monitoring of blood pressure by patients and blood pressure management by allied healthcare professionals both require further development and evaluation in larger RCTs and prospective studies, including cardiovascular outcomes. This systematic review does, however, confirm that the most effective way to manage hypertension in the community is through a structured approach
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combining systematic identification and follow-up, which will include patient self-monitoring allied with appropriate treatment with antihypertensive medications.
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Funding body
This study was supported by a Cochrane Fellowship awarded to the lead author by the Health Research Board of Ireland through competitive peer review.
Acknowledgments
We are very grateful to Margaret Burke (Cochrane Heart Group) for help with searching and to Shah Ibrahim who was an author on the original review. Our thanks also to Alison Blenkinsopp, Barry Carter, Sandy Logan, Frank Sullivan, Hayden Bosworth, Brian Haynes, David Jewell, Jim Krieger, Richard McManus, Steven Ornstein, Mike Phelan, Mary Rogers, Lin Song, Kelly Zarnke and Peter Whincup concerning clarification about individual RCTs and providing additional data. Thanks to Craig Ramsay for advice concerning factorial trials. We are grateful to Curt Furberg for facilitating contact with the investigators of US-based studies. Our particular thanks to Charlie Ford for information regarding the Hypertension Detection and Follow-Up Program (HDFP) study. Lastly, we are grateful to Debbie Farrell for administrative support.
Competing interests
The authors have stated that there are none.
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62. Tonstad S, Alm CS, Sandvik E. Effect of nurse counselling on metabolic risk factors in patients with mild hypertension: a randomised controlled trial. Eur J Cardiovasc Nurs 2007; 6(2): 160164. 63. Bulpitt CJ, Beilin LJ, Coles EC, et al. Randomised controlled trial of computer-held medical records in hypertensive patients. Br Med J 1976; 1(6011): 677679. 64. Hypertension Detection and Follow-up Program. Therapeutic control of blood pressure in the Hypertension Detection and Follow-up Program. Hypertension Detection and Follow-up Program Cooperative Group. Prev Med 1979; 8(1): 213. 65. Hypertension Detection and Follow-up Program Cooperative Group. Five-year findings of the hypertension detection and follow-up program. I. Reduction in mortality of persons with high blood pressure, including mild hypertension. JAMA 1979; 242(23): 25622571. 66. Hypertension detection and follow-up Program Cooperative Group. The effect of treatment on mortality in mild hypertension: results of the hypertension detection and follow-up program. N Engl J Med 1982; 307(16): 976980. 67. Takala J, Niemel N, Rosti J, Sievers K. Improving compliance with therapeutic regimens in hypertensive patients in a community health center. Circulation 1979; 59(3): 540543. 68. Takala J. Screening, treatment and adherence to treatment for hypertension. Scand J Prim Health Care 1983; 1(34): 114119. 69. Turnbull DA, Beilby JJ, Ziaian T, et al. Disease management for hypertension: a pilot cluster randomized trial of 67 Australian general practices. Disease Management and Health Outcomes 2006; 14(1): 2735. 70. Wetzels GE, Nelemans PJ, Schouten JS, et al. Electronic monitoring of adherence as a tool to improve blood pressure control. A randomized controlled trial. Am J Hypertens 2007; 20(2): 119125. 71. Ahluwalia JS, McNagny, SE, Kanuru NK. A randomized trial to improve follow-up care in severe uncontrolled hypertensives at an inner-city walk-in clinic. J Health Care Poor Underserved 1996; 7(4): 377389. 72. Barnett GO, Winickoff RN, Morgan MM, Zielstorff RD. A computerbased monitoring system for follow-up of elevated blood pressure. Med Care 1983; 21(4): 400409. 73. Bloom JR, Jordan, SC. From screening to seeking care: removing obstacles in hypertension control. Prev Med 1979; 8(4): 500506. 74. Cummings KM, Frisof KB, Demers P, Walsh D. An appointment reminder systems effect on reducing the number of hypertension patients who drop out from care. Am J Prev Med 1985; 1(5): 5460. 75. Fletcher SW, Appel FA, Bourgeois MA. Management of hypertension. Effect of improving patient compliance for follow-up care. JAMA 1975; 233(3): 242244. 76. Krieger J, Collier C, Song L, Martin D. Linking community-based blood pressure measurement to clinical care: a randomized controlled trial of outreach and tracking by community health workers. Am J Public Health 1999; 89(6): 856861. 77. Mrquez Contreras E, Vegazo Garcia O, Claros NM, et al. Efficacy of telephone and mail intervention in patient compliance with antihypertensive drugs in hypertension. ETECUMHTA study. Blood Press 2005; 14(3): 151158. 78. Mrquez Contreras E, de la Figuera Von Wichmann M, Gil Guilln V, et al. [Effectiveness of an intervention to provide information to patients with hypertension as short text messages and reminders sent to their mobile phone (HTA-Alert)]. Aten Primaria 2004; 34(8): 399405. 79. Pickering TG, Miller NH, Ogedegbe G, et al. Call to action on use and reimbursement for home blood pressure monitoring: executive summary: a joint scientific statement from the American Heart Association, American Society Of Hypertension, and Preventive Cardiovascular Nurses Association. Hypertension 2008; 52(1): 1029. 80. Oliveria SA, Lapuerta P, McCarthy BD, et al. Physician-related barriers to the effective management of uncontrolled hypertension. Arch Intern Med 2002; 162(4): 413420. 81. Phillips LS, Branch WT, Cook CB, et al. Clinical inertia. Ann Intern Med 2001; 135(9): 825834.
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38 Motivation/ (34065) 39 self monitor$.tw. (2518) 40 ((patient$ or program$) adj3 (educat$ or manage$ or train$ or teach$)).tw. (121066) 41 self manage$.tw. (3390) 42 ((manage$ or monitor$) adj3 (hypertension or blood pressure)).tw. (9858) 43 Health Promotion/ (31545) 44 exp Health Education/ (102113) 45 (reward$ or incentive$).tw. (25369) 46 uncontrol$.tw. (17033) 47 Self Care/ (14858) 48 or/547 (1087894) 49 4 and 48 (19344) 50 randomized controlled trial.pt. (246660) 51 controlled clinical trial.pt. (76052) 52 Randomized Controlled Trials/ (51847) 53 random allocation/ (59418) 54 double blind method/ (94259) 55 single blind method/ (11548) 56 or/5055 (416351) 57 animal/ not human/ (3141649) 58 56 not 57 (390135) 59 clinical trial.pt. (439482) 60 exp clinical trials as topic/ (197049) 61 (clin$ adj25 trial$).ti,ab. (139080) 62 ((singl$ or doubl$ or treble$ or tripl$) adj25 (blind$ or mask$)).ti,ab. (93517) 63 placebos/ (26524) 64 placebo$.ti,ab. (106301) 65 random$.ti,ab. (393128) 66 research design/ (50559) 67 or/5966 (882479) 68 67 not 57 (818962) 69 58 or 68 (840420) 70 49 and 69 (4661)
Search slightly amended for Cochrane Central Register of Controlled Trials (CENTRAL) and Embase.
e482
Systematic Review
Bailey et al18
Carnahan et al16
SBP 7.5 (14.2 to 0.8) DBP 0 (3.9 to 3.9) Control not reported
Friedman et al13
Taking BP-lowering drugs, SBP 160 mmHg or DBP 90 mmHg on average two readings
(1) Home monitoring and SBP 4.0 (3.9 to 3.1) telecommunication system DBP 4.4 (6.5 to 2.3) Weekly automated home blood Control not reported pressure recording Telephone-linked computer system to patient (2) Usual care (1) Patient self-monitoring and education (2) Usual care (1) Self-recording (2) Home visit: BP measured in their homes every 4 weeks with result given to them and physician. Both groups visited at home after 2 weeks (3) Both interventions (4) Neither intervention (1) Home blood pressure monitoring (2) Usual care (1) Self-monitoring (2) Health-education programme (3) Both interventions (4) Usual care (1) Telecommunication service with three components: automated BP at home; central processing of BP readings; weekly reports to both physician and patient (2) Usual care (1) Home blood pressure measurement: patients asked to measure BP twice weekly, mail record of BP, medications and side effects to project office every 4 weeks (2) Usual care (1) Home measurement of blood pressure by patients (2) Usual care SBP not reported DBP 3.5 (7.0 to 0.1) Control not reported SBP not reported DBP 1.0 (5.7 to 3.7) Control not reported
Males with hypertension not compliant or at goal DBP (90 mmHg) All taking BP-lowering medication for 1 year with uncontrolled hypertension (DBP95 mmHg)
No effect DBP
No effect RCT
People with uncontrolled hypertension SBP 140179 mmHg and/or DBP 90109 mmHg People with uncontrolled hypertension (SBP 160 and/or DBP 95 mmHg) Change in BP medication because: (1) SBP 140 or DBP 90 mmHg (2) Side-effects from drugs (3) SBP >180 or DBP >110 without current antihypertensive therapy Hypertension but no entry BP level required or defined
SBP 10.1 (19.8 to 0.4) DBP 6.7 (13.2 to 0.3) Control not reported SBP not reported DBP not reported Control 1.2 (0.6 to 2.7) SBP 4.8 (9.8 to 0.2) DBP 4.0 (7.7 to 0.3) Control 1.1 (0.5 to 2.3)
Rogers et al12
No effect SBP, positive effect DBP, no effect control of blood pressure Positive effect SBP, no effect DBP
Soghikian et al17
SBP 3.3 (6.4 to 0.2) DBP 1.6 (3.5 to to 0.3) Control not reported
Vetter20
Hypertension, SBP 160200 mmHg or DBP 95115 mmHg in patients who are untreated or uncontrolled Patients with poorly controlled essential hypertension, defined as systolic blood pressure > or = 140 or diastolic blood pressure > or = 90 mmHg.
SBP 0.5 (2.8 to 1.8) DBP 1.3 (2.4 to 0.2) Control 0.8 (0.6 to 1.1)
Baqu et al25
(1) The patients were given an OMRON SBP not reported No effect for blood pressure HEM-705CP automatic blood pressure monitor DBP not reported control on two occasions, for use during 15 days at Control 1.21 (0.94 to 1.58) weeks 6 and 14. Blood pressure was recorded at each visit (baseline, 6, 8, 14, 16, and 24 weeks) (2) Usual care
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Artinian et al11
SBP 26.0 (40.0 to 11.6) DBP 12.0 (21.5 to 2.5) Control not reported
Midanik et al9
Untreated patients with hypertension: SBP <180 mmHg and DBP 9099 mmHg Hypertension: SBP 140 mmHg or DBP 90 mmHg in previous 6 months or history of drug treatment Hypertension treated at outpatient hypertension clinic or general practice clinic
SBP 2.0 (7.4 to 3.4) DBP 0 (2.9 to 2.9) Control not reported SBP 8.5 (14.3 to 2.7) DBP 3.1 (6.0 to 0.2) Control not reported SBP not reported DBP not reported Control 1.3 (0.6 to 2.7)
No effect RCT
Rudd et al10
Earp et al24
No effect RCT
Billault et al27
SBP 1.1 (5.8 to 3.6) DBP 1.4 (1.5 to 4.3) Control not reported SBP 7.4 (22.5 to 7.7) DBP 7.1 (5.2 to 19.4) Control not reported
No effect RCT
Uncontrolled and non-adherent patients with hypertension Persons with hypertension (mean systolic BP of 140 mmHg and/or mean diastolic BP, DBP, of 90 mmHg on 3 separate occasions during a 3-week period), and aged 1865 years Hypertension, either: SBP 140 and/or DBP 90 mmHg
No effect RCT, very small study Positive for SBP and DBP
(1) Patient education (lifestyle intervention) SBP 10.0 (15.0 to 5.0) while participants in the (2) control group DBP 8.6 (12.3 to 4.9) were provided with routine outpatient services Control not reported and were asked to maintain their usual lifestyles, including dietary and exercise habits, for 6 months until they were reexamined. (1) IMPACT consisted of monthly 10-minute individual sessions for patients with counsellor (2) Usual care (1) Academic detailing, provision of provider-specific data about hypertension control, provision of educational materials to the provider, and provision of educational and motivational materials to patients. (2) Usual care SBP 8.5 (14.8 to 2.2) DBP 3.9 (7.1 to 0.7) Control not reported
Fielding et al30
Positive RCT
Hennessy et al31
Total of 10 696 patients with a diagnosis of hypertension cared for by 93 primary care providers. Randomised by provider (n = 93), analysed by patient (n = 7159).
Patient education No effect RCT BP 0.00 (0.73 to 0.73) DBP 1.00 (0.56 to 1.44) Control 0.83 (0.76 to 0.92) Physician education SBP 0.00 (0.73 to 0.73) DBP 1.00 (0.56 to 1.44) Control 0.83 (0.76 to 0.92) SBP not reported DBP not reported Control 0.6 (0.4 to 0.9) SBP 5.0 (9.3 to 0.7) DBP 3.0 (0.4 to 0.6) Control 1.1 (0.4 to 2.6) Improved BP control but substantially greater numbers lost to follow-up in (C) arm at 2 and 5 years Positive RCT for SBP/DBP, no effect on control of BP
Morisky et al40
BP (mmHg) entry criteria based on age: 2039: >140/90 4059: >150/95 60: 160/100
(1) Three interventions: exit interview; instructional session on adherence and follow-up care; group sessions (2) Usual care (1) Hypertension treatment and teaching programme (2) Usual care
Mhlhauser Hypertension (mean last two et al34 measurements 160 and/ or 95 mmHg).
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Systematic Review
Hunt et al32
Patients with mildly uncontrolled hypertension as defined as a last blood pressure of 140 to 159/90 to 99 mmHg from query of an electronic medical record database. Parallel, single blind, Single urban general practice over 1 year in the UK of patients with hypertension. Newly diagnosed patients with hypertension. Mean values were: (E) 156.3/95.8 (C) 160.3/96.1 Hypertension 95 mmHg
Patients randomised to intervention (1) were SBP 2.00 (4.70 to 0.70) No effect on SBP, DBP mailed two educational packets approximately DBP 2.00 (4.25 to 0.25) 3 months apart. (2) The control group Control not reported consisted of similar patients receiving usual care for hypertension. (1) Patient-held guideline with written explicit SBP 1.00 (5.73 to 3.73) No effect for SBP or exhortation to challenge care when appropriate.DBP 2.00 (4.63 to 0.63) blood pressure control (2) Usual care Control 0.98 (0.60 to 1.60) (1) Patient education: booklet; educational talks; personal tutorial (2) Usual care (1) Augmented convenience site physician care (2) Mastery learning: via audio-cassette and booklet and re-emphasised by a patient educator (3) Both interventions (4) Usual care (1) Intervention group: booklet (2) Usual care (1) Information booklet on hypertension sent out to patients (2) Usual care (1) Education: three group education sessions by nurse-health educator (2) Counselling: three individualised counselling sessions (3) Usual care: three appointments with family physician (1) Experimental group A: educational self-care intervention: pill taking; appointment keeping; dietary sodium reduction (2) Experimental group B-received additional support from family member (3) Usual care (1) Computer-generated treatment recommendations by algorithm (2) Usual physician care (1) Computer-generated feedback-monthly feedback reports (2) Education programme: three separate self-instructions (3) Both (4) Neither SBP1.3 (4.3 to 6.9) DBP 1.9 (1.1 to 4.9) Control not reported SBP not reported DBP not reported Control 0.7 (0.3 to 2.1) No effect RCT
No effect RCT
SBP not reported DBP 0.2 (4.7 to 5.1) Control not reported SBP 0.6 (3.0 to 4.2) DBP 0.4 (1.4 to 2.2) Control not reported SBP not reported DBP 3.3 (7.0 to 0.4) Control not reported
No effect RCT
Hypertension
No effect RCT
No effect RCT
Zismer et al36
SBP 15.7 (26.0 to 5.4) DBP 8.7 (15.5 to 1.9) Control not reported
SBP 1.2 (10.1 to 7.7) DBP 1.1 (3.6 to 5.8) Control not reported SBP 1.0 (8.3 to 10.3) DBP 1.0 (6.9 to 4.9) Control 1.0 (0.2 to 3.8)
No effect RCT
Evans et al44
(1) Mailed continuous to physicians 14 weekly SBP 0.8 (4.2 to 5.8) medical education instalments of information, DBP 0.3 (2.0 to 2.6) chart and follow-up appointment system to Control 0.8 (0.5 to 1.5) encourage detection and recall of patients (2) Usual care (1) Computer-based decision support system. SBP 1.5 (3.2 to 0.2) Re-enforcement by mean of telephone DBP 0.6 (1.4 to 0.2) repetitions seminar on risk intervention Control not reported (2) Usual care
No effect RCT
Hetlevik et al45
No effect RCT
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McAllister et al46
Patients with hypertension: (1) DBP >90 mmHg on treatment (2) DBP >104 mmHg not on treatment. (3) DBP >90 or <105 mmHg with complications or risk factors
(1) Compute-generated feedback to physician on individual patient; inter and intra practice DBP ranking; commentary on treatment by GP according to a stepped-care approach. (2) Control group filled out same forms but no feedback given (1) Computer-based decision support system (2) Risk chart (3) Usual care (1) Multi-method quality improvement Practice site visits 2-day network meetings in each study year (2) Usual care: received copies of practice guidelines and quarterly performance reports (1) Educational outreach delivered by specialist nurses (2) Usual care
SBP not reported DBP not reported Control 0.9 (0.5 to 1.4)
No effect RCT
Montgomery Patients with hypertension aged 6080 years taking BP-lowering et al47 drugs Ornstein et al48 Hypertension: Uncontrolled/ untreated >140/90 mmHg or on treatment. At baseline 40% (E) and 43.7% (C) had controlled BP (<140/90 mmHg) Patients with diabetes and hypertension (>140/80 mmHg)
SBP 4.0 (8.3 to 0.3) DBP 1.0 (1.2 to 3.2) Control 1.0 (0.7 to 1.6) SBP not reported DBP not reported Control 0.8 (0.7 to 0.9)
No effect RCT
Positive RCT (for BP control but not for many of the other quality indicators)
SBP not reported DBP not reported Control 1.0 (0.9 to 1.1). SBP 6.8 (11.3 to 2.3) DBP 2.1 (4.8 to 0.6) Control not reported SBP 12.0 (20.1 to 3.4) DBP 8.0 (12.0 to 0.7) Control 0.2 (0.1 to 0.5) SBP 3.3 (5.9 to 0.7) DBP 3.7 (5.1 to 2.3) Control 0.1 (0.1 to 0.2) SBP 0.0 (1.9 to 1.9) DBP 0.0 (0.7 to 0.7) Control not reported SBP not reported DBP not reported Control 0.9 (0.2 to 3.6)
No effect RCT
Patients with diabetes and (1) Chart reminder hypertension (BP level not defined) (2) Usual care Hypertension, either: 150 or 95 mmHg 140 or 90 mmHg with CVS risk factors or target organ damage (1) Pharmacist interacted with physicians and patients according to pre-specified checklist (2) Control: usual medical care (1) Nurse-based intervention: nurses trained in aging and clinical aspects of hypertension (2) Usual care from institutes clinic and mailed pamphlet about hypertension (1) Clinical pharmacist: chronic disease management in OPD setting (medical care monitored by general practice faculty) (2) Usual care by physician (1) Nurse-led care. Agreed protocol determined treatment and frequency of attendance in both groups. Target was to reduce DBP <90 mmHg (2) Usual care using same protocol (1) Work-site care by nurse management protocol: including drug regimen and regular review (2) Usual care from their own family doctors
No effect RCT
Positive RCT
Positive RCT
Hawkins et al53
Jewell et al54
New diagnosis DBP >100 mmHg aged 3039 years, >105 mmHg aged >40 years Uncontrolled DBP >95 mmHg Hypertension (DBP 95 mmHg, or DBP 9194 mmHg and SBP >140 mmHg) Hypertension 140/90 mmHg
No effect RCT
Logan et al55
SBP not reported DBP 3.9 (5.2 to 2.6) Control 0.4 (0.3 to 0.6)
Park et al56
(1) Pharmacist administered monthly patient SBP 13.0 (22.6 to 3.4) management: education, medication changes DBP 5.0 (9.9 to 0.1) verbal counselling and written information Control 0.2 (0.1 to 0.8) (2) Traditional pharmacy services SBP 6.9 (12.7 to 1.1) DBP 0.1 (4.4 to 3.2) Control not reported
Positive RCT
Solomon et al57
Treated patients with hypertension (1) Patient-centred pharmaceutical care model (employing standardised care) implemented by clinical pharmacy residents (2) Usual care A total of 71 patients in a single hospital clinic outpatient in Brazil. >18 years with uncontrolled hypertension (1) C under routine clinical management and sham intervention (2) Intervention received a pharmaceutical care programme delivered by 9 trained pharmacists: patient education and support
De Castro et al58
SBP 5.00 (12.13 to 2.13) No significant effect for SBP DBP 2.00 (7.11 to 3.11) and DBP Control not reported
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Systematic Review
Sookaneknun Adults with hypertension from hospital and 2 primary care units et al60
(1) Patients were monitored monthly by SBP 5.70 (10.28 to 1.12) Positive effect for SBP , DBP reviewing their medications and supported by DBP 2.50 (5.61 to 0.61) and BP control providing pharmaceutical care and counseling. Control 0.69 (0.41 to 1.17) (2) usual care 1) Medical clinic measurement of blood SBP 7.00 (13.45 to 0.55) Positive effect for SBP pressure by home care nurse using BpTRU DBP 0.80 (5.12 to 3.52) automated oscillometric blood pressure cuff Control not reported (2) Healthy lifestyle classes stressing a healthier dietary regimen, exercise, smoking cessation and drug adherence SBP 0.00 (5.30 to 5.30) No effect on SBP or DBP DBP 1.00 (4.81 to 2.81) Control not reported
Tobe et al61
Diagnosis of hypertension with SBP greater or equal to 130 mmHg DBP greater or equal to 80 mmHg Diagnosis of type 2 diabetes mellitus
Tonstad et al62
Subjects that participated in a Randomly allocated either to (1) monthly health screening with systolic blood nurse-led lifestyle counselling (intervention group, n = 31) or to (2) conventional primary pressure 140169 mmHg and diastolic blood pressure care (control group, n = 20) to be followed by 9099 mmHg at a minimum of lifestyle counselling. three separate readings treated or not treated with antihypertensive drugs. Hypertension, mean BP 178/105 mmHg (intervention) 177/106 mmHg (Control) (1) Computer-held records: allowed doctor to record clinical information in structured format (2) Standard hospital notes
(1) Stepped care, designed to provide rigorous, systematic, antihypertensive drug treatment with: free care; emphasis placed on clinic attendance and compliance; convenience; stepped drug treatment according to BP response; patients seen at intervals determined by their clinic status, at least every 4 months, and generally every 2 months (2) Referred care: referred to their primary sources of care, usually own physicians (1) Improved treatment system included: written instructions; card with details of BP readings, drugs prescribed, time of next appointment; appointments at 1-monthly intervals; invitation for outpatient review; appointment if defaulted on any appointment (2) Usual care
Bulpitt et al63
SBP 0.4 (5.9 to 5.1) DBP 0.2 (2.6 to 3.0) Control not reported
No effect RCT
(1) Stratum 1: 90104 Positive RCT, reduction SBP 8.2 (9.2 to 7.1) in all cause mortality as well DBP 4.2 (4.7 to 3.7) (2) Stratum 2: 105114 mmHg SBP 11.7 (13.7 to 9.7) DBP 7.6 (9.2 to 6.0) (3) Stratum 3: 115 mmHg SBP 10.6 (13.7 to 7.5) DBP 6.5 (7.4 to 5.6) Control 0.4 (0.3 to 0.5) Age 4049 SBP 3.0 (5.1 to 11.1) DBP 3.0 (1.1 to 7.1) Age 5059 SBP 3.0 (5.5 to 11.5) DBP 5.0 (0.7 to 9.3) Control 0.5 (0.2 to 1.0) No effect RCT but improved follow-up at clinic
Takala et al67,68
Hypertension, aged 4049 years, SBP 160 mmHg or DBP 95 mmHg; aged 5064 years, SBP 170 mmHg or DBP 105 mmHg.
Turnbull et al69
Mild to moderate hypertension and (1) Information communication technology SBP 0.70 (4.41 to 3.01) No effect on SBP and DBP aged between 18 and 75 years. package for risk assessment and management, DBP 0.10 (1.75 to 1.55) and blood pressure control access to a dietitian commissioned by the Control 1.90 (1.14 to 3.19) program and a tailored set of audiovisual and written material. (2) Usual care Persons were eligible if had been diagnosed with hypertension and inadequate BP control despite drugs and indication for Rx escalation Patients with hypertension (SBP 180 mmHg and/or DBP 110 mmHg) A total of 258 patients with high BP despite use SBP 2.00 (7.04 to 3.04) No effect on SBP and DBP of antihypertensive medication were randomly DBP 1.00 (3.57 to 1.57) and blood pressure control assigned to either (1) continuation of usual care Control 0.69 (0.40 to 1.19) or to the (2) introduction of electronic monitoring. (1) Mailed reminder: postcard addressed in the presence of the patient and mailed next day as a reminder to attend clinic (2) Given routine clinic appointment Return to clinic 1.4 (0.5 to 4.4) No effect RCT
Wetzels et al70
Ahluwalia et al71
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Positive RCT
Newly diagnosed hypertension SBP <140 mmHg and DBP >90 mmHg
Positive RCT
Fletcher et al75
(1) Reminder (letter or phone) to attend follow Return to clinic 0.3 up appointment at clinic, offer of assistance (0.2 to 0.7) if problems arose, followed up until attended clinic or missed two consecutive appointments (2) Usual care (1) Outreach and tracking by community health worker (2) Usual care Return to clinic 0.5 (0.3 to 0.7)
Positive RCT
Hypertension SBP 140 mmHg or DBP90 mmHg Eighty-five primary care centers in Spain, with a duration of 6 months. Patients. A total of 636 patients with newly diagnosed uncontrolled hypertension were included.
Positive RCT
(1) Control under routine clinical management; Mail intervention Positive effect on SBP, DBP (2) Mail intervention received a mailed SBP 0.30 (3.05 to 2.45) and blood pressure control message reinforcing compliance and reminding DBP 7.10 (12.05 to 2.15) depending on intervention or of the visits (15 days, 2 and 4 months) Control (3) Telephone intervention received a telephone 0.52 (0.34 to 0.79) call at 15 days, then at 7 and 15 weeks. Telephone intervention SBP 9.50 (11.95 to 7.05) DBP 0.20 (1.91 to 1.51) Control 0.57 (0.37 to 0.87) (1) Patients in the control group received their physicians usual interventions. (2) Patients in the intervention group received messages and reminders sent to their mobile phones 2 days per week during 4 months. SBP 4.70 (1.29 to 10.69) No effect SBP, DBP and DBP 1.60 (2.10 to 5.30) blood pressure control Control 0.58 (0.22 to 1.54)
Marquez et al78
a Outcomes: SBP and DBP mean difference in mmHg is reported. Negative figure favours intervention, positive figure favours control or usual care. Control of blood pressure measured according to treatment target definition in each RCT. Odds ratio less than one favours intervention. Return to Clinic: number of patients lost to follow-up at review. Odds ratio less than one favours intervention. BP = blood pressure. C = control. CVS = cardiovascular. DBP = diastolic blood pressure. E = experimental group. OPD = outpatient department. RCT = randomised controled trial. SBP = systolic blood pressure. TIME = Treatment Information on Medications for the Elderly.
e488